The Randomized OPTIMAL-ACT Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/9/2019 |
| Start Date: | February 8, 2019 |
| End Date: | January 2022 |
Optimal Target of Activated Clotting Time During Percutaneous Coronary Intervention and Outcomes: The Randomized OPTIMAL-ACT Trial
Despite the widespread adoption of recommended anticoagulation intensity ranges during
percutaneous coronary intervention (PCI), there are limited randomized clinical trials
testing specific targets for activated clotting times (ACT). The primary research hypothesis
is that in the modern cardiac catheterization laboratory, where PCI procedural duration is
relatively short, radial access with small caliber equipment is preferable, and where rates
of intracoronary stenting and dual antiplatelet therapy use is high, lower ACT targets, as
compared with higher ACT targets, will be associated with lower rates of bleeding while
having similar rates of ischemic events.
percutaneous coronary intervention (PCI), there are limited randomized clinical trials
testing specific targets for activated clotting times (ACT). The primary research hypothesis
is that in the modern cardiac catheterization laboratory, where PCI procedural duration is
relatively short, radial access with small caliber equipment is preferable, and where rates
of intracoronary stenting and dual antiplatelet therapy use is high, lower ACT targets, as
compared with higher ACT targets, will be associated with lower rates of bleeding while
having similar rates of ischemic events.
Inclusion Criteria:
- Age>18
- Referred for coronary angiography with possible coronary revascularization or
adjunctive invasive diagnostic testing (IVUS/OCT, FFR, or iFR)
Exclusion Criteria:
- Receipt of LMWH at treatment dose (not DVT prophylaxis dose) within 6 hours of
coronary angiography
- Prior GP IIb/IIIa use within the previous 72 hours
- Use of warfarin (vitamin K antagonist) or direct oral anticoagulant
- Patients on LMWH bridging strategy
- PCI within prior 30 days
- Planned use of bivalirudin as the procedural anticoagulant
- Rotational atherectomy
- Excimer laser coronary angioplasty
- Chronic total occlusions
- Patients with active bleeding disorders or bleeding diathesis
- Patients with ST-segment elevation myocardial infarction
- Patient with clinical evidence of cardiogenic shock (defined as SBP<90 mmHg for ≥30
min OR support to maintain SBP ≥90 mmHg AND evidence of end-organ hypoperfusion (urine
output <30 mL/h or cool extremities)
- Chronic kidney disease stage 4/5 (GFR 30 mL/min)
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